Estimating the number and types of applications for 11 substances added to the Authorisation List in February 2020 February 2020 - ECHA
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Estimating the number and types of applications for 11 substances added to the Authorisation List in February 2020 February 2020
2 Disclaimer This publication is solely intended for information purposes and does not necessarily represent the official opinion of the European Chemicals Agency. The European Chemicals Agency is not responsible for the use that may be made of the information contained in this document. Version Changes 1.0 First version Estimating the number and types of applications for 11 substances added to the Authorisation List in February 2020 Reference: ECHA-20-R-02-EN ISBN: 978-92-9481-396-1 Cat. Number: ED-03-20-113-EN-N DOI: 10.2823/11134 Publ.date: February 2020 Language: EN © European Chemicals Agency, 2020 Cover page © European Chemicals Agency If you have questions or comments in relation to this document please send them (quote the reference and issue date) using the information request form. The information request form can be accessed via the Contact ECHA page at: http://echa.europa.eu/contact European Chemicals Agency P.O. Box 400, FI-00121 Helsinki, Finland
3 Table of Contents EXECUTIVE SUMMARY ................................................................................................... 5 INTRODUCTION ............................................................................................................. 7 METHODS .................................................................................................................... 10 Literature search and evaluation of ECHA background documents.................................... 10 Assessment of current uses....................................................................................................... 10 Substances in articles ............................................................................................................... 10 Supplier search ....................................................................................................................... 11 Analysis of information on alternatives ....................................................................... 11 Stakeholder consultation .......................................................................................... 11 Supply chain description and assessing likelihood of applications for authorisation.............. 12 RESULTS AND DISCUSSION ........................................................................................ 12 Summary of uses and potential suppliers .................................................................... 12 Potential alternatives to substances proposed for the Authorisation List ............................ 20 Stakeholder consultation .......................................................................................... 22 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters ..................................................................... 23 Trixylyl phosphate ................................................................................................................... 24 Perboric acid, sodium salt (sodium perborate) ............................................................................. 24 2-(2h-benzotriazol-2-yl)-4,6-bis(1,1-dimethylpropyl)phenol [UV-328] ............................................ 25 Supply chain description .......................................................................................... 25 CONCLUSIONS ............................................................................................................. 27 REFERENCES ................................................................................................................ 29 APPENDIX A ................................................................................................................ 30 APPENDIX B ................................................................................................................ 33 APPENDIX C ................................................................................................................ 38
4 Tables Table 1 – Substances added to the Authorisation List on 6 February 2020 ........................................... 5 Table 2 - Substances added to the Authorisation List in 2020 ............................................................ 9 Table 3 - Summary of substance uses compiled from ECHA background documents and literature search ................................................................................................................................................13 Table 4 - Current use of substances in articles on EU market ............................................................ 19 Table 5 - Potential alternatives to 11 substances being placed on the Authorisation List .......................20 Table 6 - Classification and labelling notifications for unregistered substances on the Authorisation List .23 Table 7 - Patents owned by European companies (including in Switzerland and Norway) by substance...30 Table 8 - Substance patents by European company (including in Switzerland and Norway) ...................32 Table 9 - EU suppliers of 11 substances added to the Authorisation List in 2020 .................................33 Table 10 - Details of EU chemical suppliers for 11 substances added to the Authorisation List in 2020 ...35 Table 11 - List of substances, uses of which in mixtures and articles have been reported in the SPIN database for 2017 by Denmark, Finland, Norway and Sweden .......................................................... 38
5 Executive Summary The European Commission added 11 substances to the Authorisation List (Annex XIV to the REACH Regulation) on 6 February 2020. In the run-up to the new entries’ publication in the Official Journal, ECHA and wca1, an independent consultancy providing advice on the risk assessment of chemicals in the environment and workplace, have carried out market research to explore the likely numbers of applications for authorisation that might be received for these substances in the future (Table 1). Anticipating the potential number of applications for authorisation is instrumental for ECHA to be able to plan its staff resources, the meetings of the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) and to ensure that it has the capacity to provide timely opinions on any applications for these substances. ECHA can expect to receive few applications for the 11 substances. The only substance for which a potential applicant was found was trixylyl phosphate. Table 1 – Substances added to the Authorisation List on 6 February 2020 Substance EC number Number of applications 1,2-benzenedicarboxylic acid, dihexyl ester, branched and 271-093-5 0 linear*) dihexyl phthalate 201-559-5 0 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2- 271-094-0; 0 benzenedicarboxylic acid, mixed decyl and hexyl and octyl 272-013-1 diesters with ≥ 0.3% of dihexyl phthalate trixylyl phosphate*) 246-677-8 Some**) sodium perborate*) 239-172-9; 0 234-390-0 sodium peroxometaborate 231-556-4 0 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl- - 0 1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1- yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) *) 247-384-8 Possibly some**) 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV- 223-383-8 0 327) 1 https://www.wca-environment.com/index.php/about-us
6 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol 253-037-1 0 (UV-350) 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) 223-346-6 0 *) **) Registered substances Some = under five applications However, the market intelligence suggests that small volumes are being placed on the EU market even for the unregistered substances, so it is important to ensure that there is adequate publicity on the announcement of Authorisation List updates and to highlight to importers that these substances should not be placed on the EU market after the sunset date unless they apply for authorisation to continue specific uses of the substances. A search for information on the presence of the 11 substances in articles on the EU market revealed only limited information but indicated that some of these substances, particularly the UV substances, may be present in imported articles. Therefore, ECHA will need to consider preparing restriction dossiers according to Article 69(2) 2 of REACH after the sunset dates for the relevant substances incorporated in articles and imported into the EU have passed. The lead registrant of UV-328 posited that it is very likely that articles containing UV-328, as well as a similar substance UV-327 (and possibly other UV substances), will continue to be imported into the EU market. They, therefore, considered it essential for there to be an EU-wide restriction on articles containing these substances. Data from the Substances in Preparations in Nordic Countries (SPIN) database suggested that six of these 11 substances were placed on the market in Nordic countries. As many of them have not been registered it is likely that these are manufactured or imported by multiple actors under one tonne each in 2017(see Table 11). ECHA approached the lead registrants of the four registered Substances of Very High Concern (SVHCs)3. They stated that it is very unlikely that a market exists in the EU for these substances following their sunset dates. The specific findings were: • Trixylyl phosphate (EC 246-677-8): there is some interest in continued use for very specific applications. • 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) (EC 247-384-8): UV- 328 is currently imported to the EU as a UV absorber and light stabiliser for transparent plastics. A number of suitable alternatives are already available and the co-registrants for the substance are confident that downstream users will switch to plastics containing these substances. The registrants for UV-328 also supply these alternatives. They will cease placing UV-328 on the market after the sunset date, and do not intend to support any applications. One of the co-registrants thought that some of their downstream users, such as those in the automotive industry, may wish to apply for authorisation to support 2 After the sunset date has passed for a substance included on the Authorisation List (Annex XIV), Article 69(2) of REACH requires ECHA to consider if the use of the substance in articles is adequately controlled and, if it isn't, prepare a dossier which conforms to the requirements of an Annex XV dossier for restriction. 3 As there were no registrations of the other seven substances, ECHA was unable to approach any registrants.
7 the use of this substance in specific plastic components. This might amount to one or two applications. • Sodium perborate (EC 239-172-9; 234-390-0): This substance is currently used in niche applications in the EU. Suitable alternatives are readily available and substitution has apparently already largely occurred. It is unlikely that any applications would be received. • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC 271-094-0; 272-013-1): This is no longer used in the EU. Suitable alternatives are readily available and substitution has apparently already occurred. ECHA received useful information from the lead registrants as well as sectoral trade associations – AISE, ATIEL, CEPE, Concawe, Cosmetics Europe, ELiSANA, ETRMA, FEICA, Pinfa Plasticisers Plus and Plastics Europe – all representing downstream users. The registrants, as manufacturers or importers of the substances, were able to make definitive statements regarding whether they would place these substances on the EU market after the sunset date. This information was corroborated by confirmatory statements from sectoral trade associations as well as the main users of the substances, such as lubricant manufacturers, manufacturers of detergents, rubber and plastic products, as well as various other downstream user groups. ECHA asked the stakeholders to verify or corroborate the findings of the market survey4. While ECHA has made efforts to uncover the market situation of the 11 substances and, in particular, to predict the number of applications it would receive, it is possible that it has not been able to reach particular user groups. By publishing this report, ECHA wants to increase the awareness around the need to apply for substances placed on the Authorisation List. It also hopes that any potential applicants for authorisation would inform ECHA if they find inaccuracies in this report about their intention to apply. Introduction Title VII of the REACH Regulation concerning the authorisation procedure aims to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern (SVHCs) are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies, where these are economically and technically feasible (Article 55). The inclusion of a substance on the ‘Candidate List’ designates that the substance is an SVHC and that it may be prioritised for placing on the REACH Authorisation List (Annex XIV). The prioritisation is normally based on (1) the inherent properties of the substance, (2) high volume and (3) the use (wide-dispersive). Before sending its recommendation to the European Commission, ECHA launches a consultation 4 Stakeholders were also asked to verify whether the statements attributed to them in the report were accurate. At the request of the stakeholders, ECHA did not mention their names in the report.
8 which lasts for three months, in particular, on uses which should be exempt from the authorisation requirement (Article 58(4) of REACH). REACH allows companies to submit applications for authorisation to continue or start using substances included on the Authorisation List. The initial draft recommendation for inclusion of a substance on the Authorisation List includes (among other information) the ‘sunset date’, after which the placing on the market and the use of a substance is prohibited unless an authorisation is granted (or the use is exempt). It also includes the ‘latest application date’ (LAD) by which applications must be received if applicants want certainty on continued use of their substances after the sunset date, but when a decision (to grant or refuse the AfA) has not yet been adopted. It is still possible to submit an AfA after the LAD, but the use of the substance must cease before the sunset date if a decision on the application has not been made before then. It is also possible to submit an application after the sunset date, but it is only possible to use the substance if the authorisation is granted. On 6 February 2020, the Commission added 11 substances to the Authorisation List. ECHA needs to plan its staff resources and the workload of the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) to ensure it has the capacity to provide timely opinions on any applications for authorisation relating to these substances. Therefore, ECHA carried out market research in late 2019 and early 2020 to identify relevant industry associations and companies that are likely to be the “movers and shakers” leading the supply chains toward applications or substitution. The project’s primary objective was to generate estimates of the number of applications, the uses covered therein and the types of applications (e.g. by single downstream users, multiple downstream users or upstream actors) that may be submitted for the 11 substances (listed in Table 2). Of the 11 substances, only four are registered under REACH. This means that the other seven substances can only be placed on the EU market in amounts less than one tonne per year. ECHA has prioritised some of the substances to avoid regrettable substitution with the understanding that these are not currently used in the EU and, therefore, it is unlikely that ECHA would receive applications for these substances. The tasks of this market research project were to: - identify the companies and associations leading the supply chains towards any potential applications for authorisation (or if not, substitution); - describe the supply chains and market structures where the substances are used; - determine whether substitutes are available and being used; - describe which uses would authorisations be applied for; and - if relevant, estimate how many applications would be made, by whom and when, and for how many uses.
9 Table 2 - Substances added to the Authorisation List in 2020 Intrinsic Latest properties Substance application Sunset date referred to date in Article 57 1,2-Benzenedicarboxylic acid, dihexyl Toxic for 7 August 27 February ester, branched and linear*) reproduction 2021 2023 EC 271-093-5; CAS 68515-50-4 (category 1B) Toxic for Dihexyl phthalate 7 August 27 February reproduction EC 201-559-5; CAS 84-75-3 2021 2023 (category 1B) 1,2-benzenedicarboxylic acid, di-C6-10- alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters Toxic for 7 August 27 February with ≥ 0.3% of dihexyl phthalate (EC 201- reproduction 2021 2023 559-5) (category 1B) EC 271-094-0; 272-013-1; CAS 68515-51-5; 68648-93-1 Toxic for 27 Trixylyl phosphate*) reproduction November 27 May 2023 EC 246-677-8; CAS 25155-23-1 (category 1B) 2021 Sodium perborate; perboric acid, sodium Toxic for 27 salt*) reproduction November 27 May 2023 EC 239-172-9; 234-390-0; (category 1B) 2021 CAS 15120-21-5; 11138-47-9 Toxic for 27 Sodium peroxometaborate reproduction November 27 May 2023 EC 231-556-4; CAS 7632-04-4 (category 1B) 2021 5-sec-butyl-2-(2,4-dimethylcyclohex-3- en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec- butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)- 27 February 27 August 5-methyl-1,3-dioxane [2] [covering any of vPvB 2022 2023 the individual stereoisomers of [1] and [2] or any combination thereof] EC -; CAS - 2-(2H-benzotriazol-2-yl)-4,6- 27 November ditertpentylphenol (UV-328) *) PBT, vPvB 27 May 2022 2023 EC 247-384-8; CAS 25973-55-1 2,4-di-tert-butyl-6-(5-chlorobenzotriazol- 27 November 2-yl)phenol (UV-327) vPvB 27 May 2022 2023 EC 223-383-8;CAS 3864-99-1 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6- 27 November (sec-butyl)phenol (UV-350) vPvB 27 May 2022 2023 EC 253-037-1; CAS 36437-37-3 2-benzotriazol-2-yl-4,6-di-tert- 27 November butylphenol (UV-320) PBT, vPvB 27 May 2022 2023 EC 223-346-6;CAS 3846-71-7 *) Registered substances
10 This was the first time that ECHA carried out such market research to engage proactively with relevant stakeholders to gauge their interest in applying for authorisations for the concerned substances. This research has helped to build internal capabilities and competences for similar projects in the future. Methods This section details how the market research was undertaken to assess the market reaction to the 11 substances being classified as substances of very high concern (SVHCs) and then placed on the Authorisation List (Annex XIV), with the objective of determining the likelihood of applications for authorisation being submitted. Literature search and evaluation of ECHA background documents ECHA carried out an initial market research based on the registrations of the substance and by contacting the lead registrants and sector organisations. It then contracted wca to follow up certain aspects of the initial research. The wca project team undertook a brief review of available literature (primarily internet resources) to obtain an overview of uses of the substances and screen those within the scope of authorisation. This provided only limited information and more relevant information was obtained from ECHA ‘background documents’ such as reports detailing the proposal for identification of an SVHC (Annex XV). Assessment of current uses Information on substance uses were initially compiled from the following sources: • Annex XV reports published by ECHA; • US EPA CPCat Database (21 May 2014 release) – this details substance use information categorised by product, function and user group (industrial or consumer) from the United States (various EPA chemical datasets), Australia (NICNAS) and industry (Dow Chemical Company); • SPIN and KEMI databases (the SPIN database also provides information on the amount of a substance used in Nordic countries); and • Hazardous Substances DataBank (HSDB) and PubChem. Industrial uses were collated on the basis of substance CAS numbers. Patent searches were conducted to understand specific substance uses and industrial processes that may be situated in the EU. Searches were conducted on Derwent Innovation, based on substance CAS numbers for all available years (1900 to 2019) and European companies holding active and inactive patents were identified. Substances in articles Information on the presence of the substances in articles was gathered by wca from internet searches. The main information targeted were manufacturer/supplier declarations under REACH Article 33(1) to identify Candidate List substances in articles.
11 Searches were conducted using search terms such as ‘articles containing [substance name] [CAS number]’ (e.g. ‘articles containing dihexyl phthalate 84-75-3’). Results from the first five pages were screened and information on the types of product and manufacturer/supplier for each substance were recorded. Supplier search Chemical suppliers were identified to gain insight on the availability of substances on the European market as these suppliers may hold information on downstream uses and market demand. Searches were conducted in SciFinder based on substance CAS numbers. The substance record contains information on commercial sources, including the product quantities, purities and seller contact details. The contact details for European sellers were collated and product quantities over 1 kg (bulk) were noted. Analysis of information on alternatives The wca project team investigated whether substitutes are available for the substances placed on the Authorisation List. By reviewing Annex XV reports, the CHEMSEC database and consultation with trade associations and companies, wca could determine if there has already been any substitution (or there are plans) since substances were listed as SVHCs. Stakeholder consultation ECHA carried out a number of preliminary tasks for the project. The first of these was to approach the registrants of the substances and ask for their collaboration in this study, in particular to identify the relevant supply chains and actors therein. An initial letter was sent by ECHA to lead registrants for the 11 substances requesting that they provide information on the supply chain for each substance and their opinion on the likelihood of applications for authorisation being submitted following the substance’s inclusion on the Authorisation List. ECHA also set up a “call for information” to inform stakeholders about this work and urge actors in the supply chain to provide information on the likely response to the inclusion of these substances on the Authorisation List. ECHA also sent a letter to trade associations representing sectors concerned in the supply chain for these substances requesting them to invite member companies to participate in an online survey that requested information on: • their contact details; • whether they manufacture, import, formulate, distribute or use any of the 11 substances within the European Union?; • what the substance is used for; • whether the company is a downstream user, manufacturer, importer/only representative or distributor; • whether there was an intention to apply for authorisation to continue using the substance;
12 • whether there was a plan to apply for authorisation alone or through an upstream applicant; • whether the respondent would apply for authorisation on behalf of downstream users; and • if the respondent did not plan to apply for authorisation, what was the reason (i.e. substance will no longer be used or an alternative substance/technology has already been identified to switch to)? ECHA and the wca project team then identified companies and associations leading the supply chains toward applications for authorisation or substitution and used telephone interviews to gather relevant information. Supply chain description and assessing likelihood of applications for authorisation Based on the outputs of earlier activities, the basic supply chain and market structures for the substances were identified to help determine whether applications for authorisation are likely to be received for the substances placed on the Authorisation List in 2020. Both ECHA and the wca project team requested information from suppliers on the market for the substances, highlighting the priority uses (and substance functionality) for which authorisation is most likely to be applied for. The wca project team also requested information on how companies are organised along the supply chain to assess which are most likely to be applicants for authorisation (either alone or through a joint application). Both ECHA and the wca project team sought to determine whether there are likely to be ‘upstream applications’ (fewer in total but broader applications) or specific ‘downstream user applications’ (specific to a certain use and likely to result in a greater number of applications). Results and discussion Summary of uses and potential suppliers Information on uses of the 11 substances to be placed on the Authorisation List was compiled by the wca project team from ECHA documents and various databases covering Europe, the United States and Australia (see Section 2.1.2 for details) and is summarised in Table 3. Based on the uses identified for each substance, the most relevant European trade associations were identified and these are also detailed in Table 3. Wide-ranging uses were identified for all 11 substances, indicating the theoretical possibility of numerous applications for authorisation being submitted following the placing of these substances on the Authorisation List, and specifically for the four substances already registered under REACH. This highlighted the need for a targeted stakeholder consultation to gather up-to- date information on the supply chain and market for these substances, to pinpoint the most important uses that could drive applications and identify which actors would most likely make the application, i.e. whether this would come from manufacturers or downstream users acting alone or in a consortium.
13 Patent searches were conducted to identify European companies holding active and inactive patents (Tables 7 and 8). The results (see Appendix A) revealed that a significant number of patents are held by several European companies for most of the substances, although there are no patents held in the EU for trixylyl phosphate and sodium perborate (and only one patent held in the EU for sodium peroxometaborate). The patents are generally held by large chemical manufacturing companies and the majority are still live patents. It is uncertain what can be read from this information in terms of predicting the likelihood of applications for authorisation but the holding of live patents for most of the substances would indicate an ongoing commercial interest in them that has the potential to motivate submission of applications for authorisation. Table 3 - Summary of substance uses compiled from ECHA background documents and literature search Regis- Relevant tered Substance Use summary industry (Yes/ associations No) 1. Plasticiser (sealant/jointing agents in US market) in polymers. Occurring in Plastics Europe, European Tyre consumer articles. Automotive gear 1,2- & Rubber lubricant on German market. Possible Benzenedicarboxylic Manufacturers’ replacement for other low/transitional acid, dihexyl ester, Yes Association branched and linear phthalates being phased out (ECHA (ETRMA), EC 271-093-5 2014a). Concawe CAS 68515-50-4 2. Rubber and plastic products. (petroleum 3. Lubricants and additives, gear oils, refining), ATIEL automotive. (lubricants) 1. Plasticiser for cellulose and vinyl plastics. DnHP is used in the making of plastisols that are subsequently used to manufacture automobile parts (air filters, battery covers) and dip- moulded products (tool handles, dishwasher baskets). Substances containing DnHP may also be used in traffic cones, toys, vinyl gloves, weather stripping, flea collars, shoes, Dihexyl phthalate No and conveyor belts used in food Plastics Europe, EC 201-559-5 packaging operations. Due to its ETRMA CAS 84-75-3 similar physicochemical properties to other transitional phthalates with C4- C6 carbon backbone lengths, dihexyl phthalate can possibly be used as a substitute for these phthalates (ECHA 2013a). 2. Rubber and plastic products, inert pesticides, children’s products. 4. Commercial phthalate substances containing DnHP may be added to the
14 Regis- Relevant tered Substance Use summary industry (Yes/ associations No) PVC utilised to manufacture flooring, canvas tarps, and notebook covers. DnHP is often found as a minor component (less than 1 %) of C6-10- phthalate mixtures; it may also be an isomer in mixtures of diisohexyl phthalates (DIHP) (CAS RN 68515-50- 4) at levels of 25 % or lower. 1. Phthalates are well known to be used as plasticisers and lubricants, and the registered uses of the substance are 1,2- for example in adhesives, lubricants, benzenedicarboxylic coatings, building material, cable acid, di-C6-10-alkyl compounding, polymer foils, PVC esters; 1,2- compounds and artist supply (ECHA benzenedicarboxylic 2015a). FEICA acid, mixed decyl 2. Rubber and plastic products, (adhesives and and hexyl and octyl No adhesives, sealants, plasticisers, sealants), diesters with ≥ custom compounding of purchased Plasticisers 0.3% of dihexyl resins (CAS 68648-93-1). Plus, Plastics phthalate (EC 201- 3. Adhesives, binding agents, resins for Europe, ETRMA 559-5) EC 271-094-0; 272- 1- and 2-component hardening 013-1 adhesives, softeners (CAS 68515-51- CAS 68515-51-5; 5). 68648-93-1 4. Plasticiser in PVC products and in paints and can also be used in adhesive and lubricant materials. 1. TXP is mainly used as a functional fluid (fire resistant fluids, hydraulic fluids, lubricants, lubricant additives, grease products, metal working fluid) and as a flame retardant in the production of plastics. Internet sources recommend TXP mixtures as a plasticiser of vinylite, cellulosic resin and natural and synthetic rubber. It may also be Concawe, Trixylyl phosphate Yes ATIEL, Pinfa EC 246-677-8 used for anti-mildew cables, electricity (flame CAS 25155-23-1 and as a plasticiser and flame retardants) retardant for PVC convey belts, artificial leather and flooring materials1 (ECHA 2013b). 2. Greases, petroleum lubricating oil and grease manufacturing. 3. Flame retardant, lubricant and additives, manufacture of computer, electronic and optical products.
15 Regis- Relevant tered Substance Use summary industry (Yes/ associations No) 4. Flame retardant plasticiser for wire and cable insulation usually used in blends with phthalates. The major current area of use is in power generation fluids. 1. Used as a source of oxygen in laundry detergents and peroxide-based bleaches. Mainly used as a bleaching agent in laundry detergents and machine-washing products (clothes). Cosmetic products. Other minor uses include non-agricultural pesticides and preservatives, conductive agents and cleaning/washing agents for dishwashing machines. Also, used as a bleaching agent in denture cleansers and stain removers (cited from 2007 risk assessment report) (ECHA International 2014b). Association for Sodium perborate; 2. Personal care products, fracking, Soaps, perboric acid, biocides, antimicrobials, fragrances, Detergents and sodium salt Yes pharmaceuticals, inert pesticides. Maintenance EC 239-172-9; 234- 3. Cleaning and washing agents, Products 390-0 conductive agents, non-agricultural (AISE), CAS - pesticides/preservatives, bleaching Cosmetics agents, building materials/additives, Europe, dyestuff/pigments, textile auxiliaries, Concawe photo chemicals. 4. Denture cleaner, oxygen source (e.g. oxidiser in tooth powders and toothpaste). Topical antiseptic. Bleaching agents for textiles; component of detergents, mouthwash; laboratory reagent; agent in neutralising cold wave preparation; electroplating agent; germicide; deodorant; agent in developing vat dye. 1. As for sodium perborate (ECHA 2014c). Sodium 2. Food additive, inert pesticides, active AISE, peroxometaborate No biocide, fracking. Cosmetics EC 231-556-4 3. Cleaning agent, laundry and Europe CAS 7632-04-4 dishwashing products, surface treatment, and cosmetics.
16 Regis- Relevant tered Substance Use summary industry (Yes/ associations No) 1. Information on use is ‘confidential and therefore cannot be provided’ (ECHA 2015b). 3. CAS 117933-89-8 used in cosmetics and PCPs. ECHA has no public 5-sec-butyl-2-(2,4- dimethylcyclohex-3- registered data indicating whether or en-1-yl)-5-methyl- in which chemical products the 1,3-dioxane [1], 5- substance might be used5. Stated to sec-butyl-2-(4,6- be manufactured and/or imported in dimethylcyclohex-3- the European Economic Area in 1-10 en-1-yl)-5-methyl- tonnes per year. Raw material for 1,3-dioxane [2] No cosmetic manufacturing, fragrance Cosmetics [covering any of the (CAS 117933-89-8). Europe individual 4. PubChem: Cleaning/washing, stereoisomers of fragrance (consumer use), chemical [1] and [2] or any manufacturing, raw material for combination personal care products/cosmetics thereof] 5. Known as amber dioxane6 and used as EC - a woody fragrance in PCPs. Trade CAS - name is Karanal; alternative CAS given as 186309-28-4 (available from China). Recently used in a number of perfumes. 1. UV absorber. Phenolic benzotriazoles are technically the most important UV absorbers and specifically for transparent plastics. UV stabiliser in plastic shrink films (including food packaging), outdoor furniture and clear coat automotive finishes. UV-328 2-(2H-benzotriazol- is also used for light stabilising in 2-yl)-4,6- coatings, Acrylonitrile butadiene CEPE (inks and ditertpentylphenol styrene resin, epoxy resin, fibre resin, pigments), Yes propylene and polyvinyl chloride. It is (UV-328) Plastics Europe, EC 247-384-8 also effective in light stabilisation of FEICA, ETRMA CAS 25973-55-1 unsaturated polyester, polyacrylate and polycarbonate (ECHA 2014d). 2. Consumer fragrances, fabric/textile/leather products, furniture/furnishings, inert pesticides, automotive. 3. Construction materials, fillers, surface treatment, adhesives, 5 https://echa.europa.eu/substance-information/-/substanceinfo/100.120.617 6 http://www.thegoodscentscompany.com/data/rw1038591.html
17 Regis- Relevant tered Substance Use summary industry (Yes/ associations No) intermediates/additives in plastics manufacture, paint/lacquers/varnishes, reprographic agents, printing inks, raw materials for production of plastic, manufacturing of machinery/equipment/transport equipment, manufacture of basic/fabricated metals, serigraphic printing. 4. UV stabiliser in polyolefin films, outdoor furniture and clear coat automotive finishes. Used as a UV absorber in plastic applications. Particularly recommended for polyolefins, polyurethanes, PVC, polyacrylate, epoxy, and elastomers. 1. One company indicated that 50 % of all of their products of this substance class are used as UV-protection agents in coatings especially for cars and special industrial wood coatings. Ca. 40 % are used as UV-protection agents for plastics, rubber and polyurethanes. The rest is used in cosmetics (e.g. as sun protection agents). UV stabiliser for a wide range of plastics and articles, for example: polycarbonates, acrylic polymers, 2,4-di-tert-butyl-6- polyester (saturated and unsaturated), (5- styrene mono- and copolymers, CEPE (inks and chlorobenzotriazol- No polyvinyl chloride, polyolefins, pigments), 2-yl)phenol (UV- polyvinylbutyle, and polyurethanes. Plastics Europe, 327) UV-327 is also a UV stabiliser for FEICA, ETRMA EC 223-383-8 CAS 3864-99-1 rubber and constituents in formulations used for coating of surfaces, e.g. cars or special industrial wood coatings (ECHA 2015c). 2. Drinking water and food contact material. 3. Adhesive, binding agent, automotive, construction material, colouring agent, filler, tightening material (putty), manufacture of rubber and plastic products, paint, lacquers and varnishes, reprographic agent, serigraphic printing, printing inks,
18 Regis- Relevant tered Substance Use summary industry (Yes/ associations No) sealing compounds, UV stabilisers, raw material for plastics production. 2-(2H-benzotriazol- 2-yl)-4-(tert-butyl)- 1. As for UV-327 (ECHA 2015d). 6-(sec-butyl)phenol No (UV-350) 2. UV stabiliser. EC 253-037-1 CAS 36437-37-3 1. According to general knowledge on phenolic benzotriazoles, it is expected that UV-320 will be used as UV stabiliser for plastics, polyurethanes 2-benzotriazol-2-yl- and rubber and constituent in 4,6-di-tert- formulations used for coating of butylphenol (UV- No 320) surfaces, e.g. cars or special industrial EC 223-346-6 wood coatings. Constituent in rubber CAS 3846-71-7 and plastic products (ECHA 2014e). 2. Manufacturing rubber and plastic products, automotive, absorbent and adsorbent, UV stabiliser. Sources: 1. ECHA Annex XV report for the substance. 2. Information compiled from US EPA CPCat Database. 3. SPIN/KEMI. 4. HSDB/PubChem. An internet search for the presence of the 11 substances in articles on the EU market did not yield results for the majority of the substances, with the exception of the three substances detailed in Table 4. Two of the phthalates (CAS 84-75-3 and 68515-51-5/68648-93-1) are listed as constituents of Christmas decorations and one of them (dihexyl phthalate) is listed as occurring in consumer electronics and aerospace applications. Sodium perborate is listed as a constituent of a magnetic tripod7. The volume used seems to be low and the production seems to take place outside the EU. As such, this niche use of the substance is unlikely to result in an application. There is also ongoing use of this substance in antiseptic mouth rinse8 and as a bleaching agent in a product imported 7 https://www.festool.ch/de-ch/zubehoer/499814---ma-kal 8 https://www.mouthulcers.co.uk/amosan- bocasan?gclid=EAIaIQobChMIo8iE4PqC5QIVD44YCh1ESgjdEAkYAiABEgJePvD_BwE#.XZdqj1VKipo
19 from the US9 but these uses are unlikely to be continued once the substance is placed on the Authorisation List as virtually all oxygen bleaches now use sodium percarbonate as an alternative to sodium perborate. Table 4 - Current use of substances in articles on EU market Registered Substance Articles (Yes/No) Consumer electronics, Dihexyl phthalate No aerospace applications (CAS 84-75-3) Christmas decorations 1,2-Benzenedicarboxylic acid, di-C6-10- alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters No Christmas decorations with ≥ 0.3% of dihexyl phthalate (CAS 68515-51-5, 68648-93-1) Sodium perborate; perboric acid, sodium salt Yes Electric tools (CAS 11138-47-9) ECHA undertook a search of the SPIN database (Table 11), which indicated that several of the substances are used in Nordic countries alone in volumes of several tonnes per year, including one substance not currently registered under REACH (UV-327). This is likely to be because the substance is imported by multiple importers under one tonne each from outside of the EU. The list of the substances for which entries have been recorded in the SPIN database for 2017 is given in Appendix C. The latest information available in the SPIN database is from 2017 (i.e. there are no data records for 2018 and 2019). Given the absence of data for the last two years, it is not possible to fully assess the recent trends in the use of the concerned substances or to ascertain whether their uses have been discontinued. An internet search for commercial suppliers of the 11 substances indicated a number of suppliers worldwide for all substances and the existence of EU suppliers for most of the substances (except sodium perborate), although there was only one EU supplier identified for the following substances: • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate; • 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl- 2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane; and • UV-350. A full list of all suppliers identified by this search is provided in Tables 9 and 10 of Appendix B. The results of this search indicate the existence of an active market for most of the substances although it is uncertain what the actual size of the market is and whether the amount placed on 9 https://uk.ninthavenue.com/products/sodium-perborate-granular-1-lb?gclid=EAIaIQobChMI-P- pufuC5QIVGomyCh3SIAxKEAkYEiABEgL4GvD_BwE
20 the EU market exceeds the one tonne per year threshold for registration under REACH (it was only possible to determine where quantities greater than 1 kg are available and this is indicated in Table 10 in Appendix B). Potential alternatives to substances proposed for the Authorisation List A brief assessment of potential alternatives indicated that a number of possible alternatives are available for each of the 11 substances placed on the Authorisation List; these are detailed in Table 5. The consultation with registrants and sectoral trade associations indicated that substitution has already taken place for three of the four substances that are currently registered under REACH, either following or shortly before their designation as substances of very high concern (SVHCs). Sodium perborate has been replaced by the less toxic but equally effective sodium percarbonate. 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear has been replaced by other plasticisers, and trixylyl phosphate is no longer placed on the EU market, having been replaced by other flame retardants in its previous main use in lubricants and other functional fluids. Non-SVHC listed light stabilisers are available as substitutes for UV-328 and it is envisaged that they will be phased in during the run up to the sunset date; with the most appropriate replacement depending upon the specific end use. UV-328 is a phenolic benzotriazole and while other substances from this chemical class have hazardous properties and are also proposed for the Authorisation List, other related benzotriazoles are not SVHCs and can be used as substitutes. Other possible UV absorbers and light stabilisers include benzophenones and hindered amine light stabilisers (HALS), which also protect plastics from UV radiation but are not UV absorbers, instead functioning as degradation inhibitors by acting as proton-donators. Table 5 - Potential alternatives to 11 substances being placed on the Authorisation List Substance Source of information Alternative substances could be other phthalates 1,2-Benzenedicarboxylic acid, dihexyl with short or long carbon backbones, depending on ester, branched and linear the physicochemical property needed10 (ECHA EC 271-093-5 2014a). CAS 68515-50-4 Various options depending on phthalate function11. 10 However, these may have similar reprotoxic effects as 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear. 11 https://chemsec.org/publication/endocrine-disruptors,substitution/replacing-phthalates
21 Substance Source of information Alternative substances might be phthalates with short or long carbon backbones, depending on the physicochemical property needed. Depending on the functionality needed, chemicals like citrates (biodegradable and not toxic), adipates, phosphates (resistant to ignition and burning), trimellitates (exceptional thermal properties.) etc. Dihexyl phthalate could be used as alternatives of dihexyl phthalate. EC 201-559-5 Potential alternatives as assessed in the case of the CAS 84-75-3 restriction proposal for bis(2-ethylhexyl)phthalate (DEHP, CAS 117-81-7), Benzyl butyl phthalate (BBP, CAS 85-68-7), Dibutyl phthalate (DBP, CAS 84-74-2), and Diisobutyl phthalate (DIBP, CAS 84- 69-5) could be of interest for dihexyl phthalate (ECHA 2013a). Various options depending on phthalate function15. 1,2-benzenedicarboxylic acid, di-C6- 10-alkyl esters; 1,2- Substance itself containing less than 0.3 % (w/w) benzenedicarboxylic acid, mixed decyl of dihexyl phthalate (ECHA 2015a). and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC 201-559-5) Various options depending on phthalate function15. EC 271-094-0; 272-013-1 CAS 68515-51-5; 68648-93-1 Other phosphate esters, e.g. BuTTP (less problematic triarylphosphate) or polyol esters are Trixylyl phosphate alternatives as hydraulic fluids. Isopropylphenyl EC 246-677-8 diphenyl phosphate (IPDPP) and tris- CAS 25155-23-1 (isopropylphenyl) phosphate (IPPP) are alternatives for PVC products and lubricants (ECHA 2013b). Sodium perborate; perboric acid, In the EU, sodium perborates have almost sodium salt exclusively been replaced by the alternative sodium EC 239-172-9; 234-390-0 percarbonate, which is less toxic (ECHA 2014b). CAS - 15120-21-5; 11138-47-9 Sodium peroxometaborate EC 231-556-4 As for sodium perborate (ECHA 2014c). CAS 7632-04-4
22 Substance Source of information 5-sec-butyl-2-(2,4-dimethylcyclohex- 3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex- Information on alternatives is ‘confidential and 3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual therefore cannot be provided’ (ECHA 2015b). stereoisomers of [1] and [2] or any combination thereof] EC / CAS - Other phenolic benzotriazoles (but may also have PBT/vPvB properties). Benzophenones are other technically important UV absorbers for transparent 2-(2H-benzotriazol-2-yl)-4,6- plastic materials but may be potential endocrine ditertpentylphenol (UV-328) EC 247-384-8 disruptors. Hindered amine light stabilisers (HALS) CAS 25973-55-1 also protect plastics from UV radiation – not UV absorbers but function as degradation inhibitors by being proton-donators (ECHA 2014d). 2,4-di-tert-butyl-6-(5- chlorobenzotriazol-2-yl)phenol (UV- As above for UV-328 and other potential alternative 327) substances acting as UV stabilisers are triazines, EC 223-383-8 oxanilides, and cyanoacrylates (ECHA 2015c). CAS 3864-99-1 2-(2H-benzotriazol-2-yl)-4-(tert- butyl)-6-(sec-butyl)phenol (UV-350) As for UV-327 (ECHA 2015d). EC 253-037-1 CAS 36437-37-3 2-benzotriazol-2-yl-4,6-di-tert- butylphenol (UV-320) As for UV-328 (ECHA 2014e). EC 223-346-6 CAS 3846-71-7 Sources: ECHA Annex XV report for the substance and ChemSec Marketplace12. Stakeholder consultation The stakeholder consultation led by ECHA focused on four of the 11 substances to be placed on the Authorisation List that had active REACH registrations when the project commenced at the beginning of September 2019, i.e. EC CAS EC Name 271-094-0 68515-51-5 1,2-benzenedicarboxylic acid, di-c6-10-alkyl esters 246-677-8 25155-23-1 trixylyl phosphate 234-390-0 11138-47-9 perboric acid, sodium salt 247-384-8 25973-55-1 2-(2h-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) The results of the stakeholder consultation detailed in this section of the report for these four substances are a combination of responses received by both ECHA and the wca project team. 12 https://chemsec.org/business-tool/marketplace
23 ECHA investigated PPORD13, substances in articles14, and C&L notifications15 for the seven unregistered substances. ECHA investigated PPORD16, substances in articles17, and C&L notifications18 for the seven unregistered substances. It has been observed that ECHA has received only one substance in article notification for 2,4-di-tert-butyl-6-(5-chlorobenzotriazol- 2-yl)phenol (UV-327), whereas no PPORD notification has been received for any of the substances. On the other hand, C&L notifications have been received for the six substances detailed in Table 6. Table 6 - Classification and labelling notifications for unregistered substances on the Authorisation List Total number Number of Number of of members notifications not EC Number EC Name group part of the submitted on notifications group behalf of a notifications group 201-559-5 dihexyl phthalate 3 27 5 2-benzotriazol-2-yl-4,6-di- 223-346-6 3 104 15 tert-butylphenol 2,4-di-tert-butyl-6-(5- 223-383-8 chlorobenzotriazol-2- 16 373 54 yl)phenol 231-556-4 sodium peroxometaborate 6 159 18 2-(2h-benzotriazol-2-yl)-4- 253-037-1 (tert-butyl)-6-(sec- 5 147 8 butyl)phenol 1,2-benzenedicarboxylic 271-093-5 acid, dihexyl ester, 2 14 2 branched and linear It is impossible to infer from C&L notifications whether any of the notifiers still use the substance, even more so, whether they intend to submit an application for authorisation. ECHA sent a short survey to the notifiers to gauge their potential interest in submitting an application for authorisation in the future. Only one response was received. Given the absence of responses it may be inferred with some degree of certainty that the notifiers did not have a particular interest in applying for authorisation for the given substances. It is also possible that the notifiers no longer use the substances. 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters The lead registrant for this substance indicated to ECHA that they ceased production of the substance in the EU approximately two years ago, after the substance was identified as a 13 https://echa.europa.eu/support/dossier-submission-tools/reach-it/ppord 14 https://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles 15 https://echa.europa.eu/regulations/clp/cl-inventory/notification-to-the-cl-inventory 16 https://echa.europa.eu/support/dossier-submission-tools/reach-it/ppord 17 https://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles 18 https://echa.europa.eu/regulations/clp/cl-inventory/notification-to-the-cl-inventory
24 substance of very high concern (SVHC) and it became apparent that it was likely to be placed on the Authorisation List. The lead registrant was the only manufacturer of the substance in the EU (and worldwide) and their registration status is currently “inactive”. 1,2-benzenedicarboxylic acid, di-c6-10-alkyl esters was used as plasticiser for very niche and specific applications and the registrant manufactures other (non-SVHC listed) plasticisers that are suitable alternatives for the required functions. They, therefore, consider that there is no need to continue manufacturing the substance and were definitive in their assertion that there would not be any applications for authorisation for this substance, especially as imported articles cannot contain this substance, as the lead registrant was the only global manufacturer. Trixylyl phosphate Regarding trixylyl phosphate, ECHA received opinions from both the current lead registrant, and the trade association ATIEL (representative body of the European lubricants industry). The lead registrant does not intend to support any applications for authorisation. However, one of the customers of the co-registrant intends to make a downstream application for the use of the substance in power plant turbines. ATIEL reported that the use of trixylyl phosphate has been discontinued by all of its members (i.e. manufacturers of lubricants). Evaluation of EU downstream uses has shown that acceptable alternatives are available and are already being used in the EU. At the appropriate time before an established sunset date, the registration dossier will be updated by the lead registrant to delete all authorisable uses. Discussions within the Phosphate ester Flame Retardants (PFR) Consortium will be held to transfer the lead registration to another member if one does intend to support end uses within the EU. Perboric acid, sodium salt (sodium perborate) ECHA determined that there are currently only two manufacturers of sodium perborate in the EU. Both manufacturers largely export outside the EU. However, one of them still continues to supply the substance for very few specific applications in the EU. One former manufacturer, and original member of the REACH Registration Consortium for sodium perborate, completely stopped manufacturing sodium perborate before the substance was identified as a substance of very high concern (SVHC) and added to the Candidate List in 2014. This was largely their business decision unrelated to REACH. The main uses for sodium perborate nowadays are in the oil and gas industry, whereas formerly they were widely used in powder detergents below specific concentration limits. Several sources have confirmed to ECHA that sodium percarbonate is the main alternative substance to replace sodium perborate and that it fully meets functionality/performance requirements without the hazards associated with sodium perborate. A former manufacturer stated that they switched to manufacturing sodium percarbonate after discontinuing the manufacture of sodium perborate. Another company manufactures both sodium perborate and sodium percarbonate. Both manufacturers had many EU-based customers, but when discussions started that the substance might be listed as an SVHC, the detergent industry started slowly moving away from sodium perborate and they lost most of their EU customers. Additionally, the detergent industry has moved rapidly towards liquid detergent (as opposed to powder-based products) meaning that overall demand for both sodium perborate and its main alternative sodium percarbonate
25 has seen a rapid decline as both substances are used as solids. Given these developments, both existing manufacturers of sodium perborate stated that they do not see any business sense in applying for authorisation in the hope of ‘winning back the lost customers’. These customers would not want to switch back to sodium perborate anyway, given that a safer (non-SVHC listed) alternative is already readily available on the market at a reasonable/competitive price. 2-(2h-benzotriazol-2-yl)-4,6-bis(1,1-dimethylpropyl)phenol [UV-328] Both registrant and co-registrant stated that 100 % of the UV-328 is imported into the EU, mainly from Asia as a pure substance or in mixtures. The substance is not used as an intermediate or monomer. One registrant stated that they will supply the substance until the sunset date but they will not apply for authorisation on their own as they already have several viable alternatives to UV-328 that are not substances of very high concern (SVHCs) (e.g. phenolic benzotriazoles that are non- PBT and non-vPvB) and see little value in preparing an application given the number of economically/technically feasible alternatives. However, there is a possibility that some of their downstream users (e.g. the automotive industry) may submit an application if they were confronted with a lengthy and involved ‘recertification process’ for parts. This was thought to result in no more than one or two applications from the automotive industry. The registrant expressed a concern that after UV-328 and the other phenolic benzotriazoles stabilisers (e.g. UV-327 and UV-350, which are unregistered) are officially added to the Authorisation List, the import of articles containing these substances will continue from outside the EU. The registrant, therefore, expressed the view that industry should strongly advocate for EU-wide measures to address this. The co-registrant for UV-328 confirmed that they had similar views and stated that they will not continue to import and supply UV-328 after the sunset date. They will not submit an application on their own and do not expect any of their downstream users to submit it either, as there are readily available alternatives as UV stabilisers, which they also market (these were stated to be non-benzotriazoles but further details were considered commercially sensitive and confidential). Following discussion with the wca project team, the sectoral trade association for downstream users of this type of substance, ELiSANA (European Light Stabilisers and Antioxidants Association) publicised this project to their members and encouraged them to make contact if they anticipated submitting an application for UV-328 or other related substances to be placed on the Authorisation List. No responses were received, which is another indication that ECHA is unlikely to receive applications for continued use of these substances. Supply chain description There is no supply chain to consider for 1,2-benzenedicarboxylic acid, di-c6-10-alkyl as it is no longer manufactured in the EU. Sodium perborate is no longer placed on the EU market by one of the two existing European manufacturers, who only exports their product to countries outside of the EU. The other manufacturer still supplies the substance for very niche applications in the EU and may continue to do so until the sunset date. It appears that there is a small residual market for bleaching
You can also read